Intervention Study on Digital Health Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bracelet, assistant, APP: the "golden triangle" of smart life.
- Who it may be relevant to
- Registry conditions: Hypertension, Hyperlipidemia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intervention of a Digital Health Management Program in Patients With Cardiometabolic Disorders: a Real-world Study
Overview
The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of "monitor-feedback-optimization" based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from "generalized intervention" to "precise regulation". By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of "digital therapy" can be promoted for the prevention and control of chronic diseases in China
Interventions
- Other Bracelet, assistant, APP: the "golden triangle" of smart life
The lifestyle intervention was carried out through the bracelet, Little Assistant and Keyhealth APP for 24 weeks, and the daily data synchronization of the APP and weekly AI feedback were performed. After 24 weeks, blood glucose, blood lipid, blood pressure, CAI and other indicators were monitored.
Primary outcome measures
- Changes in diastolic blood pressure after 24 weeks [Time frame: 24 weeks following intervention]
Secondary outcome measures (1)
- Values for changes in Hba1c or BMI or CAI after 24 weeks [Time frame: 24 weeks following intervention]
Eligibility criteria
Inclusion Criteria:1. Age 18-65 years old; 2. Meet one of the following three conditions:
- Diastolic hypertension (systolic blood pressure < 140 MMHG and diastolic blood pressure ≥90mmHg)
- Glycosylated hemoglobin (6.0-6.5)
- Obesity (BMI≥28kg/m²)
- Mild hyperlipemia: total cholesterol (TC) ≥5.2 mmol/L and < 6.2 mmol/L, or low-density lipoprotein cholesterol (LDL-C) ≥3.4 mmol/L and < 4.1 mmol/L 3. Antihypertensive or lipid-lowering medications have not been started 4. Use a smartphone and volunteer
Exclusion criteria
- Complicated with chronic liver and kidney disease, coronary heart disease, heart failure and severe valvular disease
- Previous cardiovascular and cerebrovascular events
- Diastolic blood pressure ≥99mmHg
- Glycated hemoglobin ≥6.5
- Other life expectancy such as cancer is less than 5 years
- Participate in other clinical trials
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Cardiology,Shanghai Tenth People's Hospital — Shanghai
Identifiers
NCT: NCT06949306 · NSS_3.0